Personal protective equipment (PPE) is a piece of equipment which is designed and manufactured to be worn or held by an individual for protection against one or more risks to the health or safety of that person.
Protective clothing is also classified as PPE.

Only protective clothing (and other PPE) that are in category II and III have to be certified by a notified body before bringing it the first on the market. For category I products this shall not apply.
All protective clothing shall be provided with the CE mark.

The presence of the CE mark in itself is a legal statement that the manufacturer or importer of the product complies with the legal requirements. Also the manufacturer or importer has to draw up a declaration of conformity and make it available.

This depends on the nature of the product. A product with a higher safety or health risk (cat. III) needs surveillance after the EU type examination where the manufacturer shall comply with certain procedures such as quality assurance, product quality assurance, product testing, unit testing or full quality assurance. Products whereby a Notified Body is involved in the production control phase the CE mark shall followed by the identification number of the respective Notified Body.

The manufacturer or importer is responsible for initiating the approval process. Depending on the risk category of the product he may need the intervention of a Notified Body. These organizations provide the actual testing and will perform the EU type examination.

Notified Bodies are designated by the Member States to carry out the conformity procedures set out in the PPE Directive or Regulation. Notified Bodies must meet certain requirements with respect to technical competence, independence, impartiality and integrity. Notified Bodies are periodically audited by the accreditation organizations. States have to permit products certified by Notified Bodies notified by other Member States.
A current list of all registered Notified Bodies can be found in the so-called. NANDO list (http://ec.europa.eu/enterprise/newapproach/nando)

The rules apply to all products marketed in the EU regardless of their country of origin. Non-European manufacturers have to designate an authorized representative or an importer take over their responsibilities.

The CE mark is a sign of conformity. The product does not necessarily conform to the EN standards but meets the essential health and safety requirements for the Directive/Regulation.

An EN standard is a technical regulation in which the technical requirements of a product is expressed. In general, an EN standard specifies the minimum requirements that a product must meet. A customer can always demanding more than required by the standard.

(Harmonized) standards are subject to change by, for example changing insights or editorial changes. Therefore, standards are periodically revised. To clarify which version of the standard one is dealing with, the year of publication of the standard is inserted after the standard number. Products placed in the market before a standard change and thus based on a at that moment outdated standard version can remain on the market. New products needs to be developed and produced based on the latest standard version.
A younger standard usually implies an improvement of the product.